Package for sterile storage of surgical devices and accessories



April 25, 1967 Filed Oct. 22, 1965 H. C; R. LZNHOLDT ETAL PACKAGE FORSTERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES 3 Sheets-Sheet l i25, 1967 H. c. R. LQNHOLDT ETAL 3,

PACKAGE FOR STERILE STORAGE OF SURGICAL DEVICES AND ACCESSORIES FiledOct. 22, 1965 3 Sheets-Sheet 2 Fig.6 0 .7

R. LQNHOLDT ETAL PACKAGE FOR STERILE STORAGE OF SURGICAL April 25, 1967DEVICES AND ACCESSORIES 3 Sheets-Sheet :3

Filed Oct. 22, 1965 United States Patent 3,315,802 PACKAGE FUR STERILESTORAGE OF SURGICAL DEVICES AND ACCESSORIES Hans Christian RannowLnholdt, Espergaerde, and Knud Maro Henrik Bjarngzl, Stenlose, Denmark,assignors to Novo Terapeutisk Laboratorium A/, Copenhagen, Denmark, aDanish joint-stock company Filed Oct. 22, 1965, Ser. No. 501,752 Claimspriority, application Denmark, June 21, 1963,

2,966/ 63 Claims. '(Cl. 206-56) This application is acontinuation-in-part of application Ser. No. 376,116, filed June 18,1964, and now abandoned.

In surgery use is as known being made of a series of different devices,accessories and auxiliaries. The demand on sterility of such devices,accessories and auxiliaries is still increasing. Among said devices,accessories and auxiliaries may e.g. be mentioned suture and ligaturematerials, haemostatic forcets, wound retractors and wound clips,knives, scissors, forcep and catheters.

As far an a series of the said devices and auxiliaries are concerned,sterilization takes place in the hospitals, preferably by autoclaving,in that the devices or auxiliaries having been wrapped separately orseveral together are put into a tray or bowl which is placed into anautoclave and is autoclaved. This applies e.g. to peans, woundretractors and wound clips and to knives and scissors. The sterilizedarticles are then removed the very moment when they are to be used orthey are put in unwrapped condition on the operating table in such casewhere they are to be at disposal with a very shtort notice.

Other devices, such as suture and ligature materials with appertainingneedles, if any, are sterilized on an industrial basis outside thehospitals. Thus, they are presented in sterile sealed packages which areto be opened before use.

The present invention relates to a package for sterile storage of sutureand ligature materials, peans, wound retractors, knives, catheters andother surgical devices and auxiliaries, and the object of the inventionis to provide a package which on one hand reduces the danger ofinfection due to contamination of the sterile surgical devices andauxiliaries prior to their use, and on the other hand renders possiblean easy and quick removal of the devices and auxiliaries from thepackages.

The package according to the invention is of the kind which consists inor contains a bag destined for taking up the surgical articles, and itis characterized by the fact that the side-Walls of said bag are slittedup from the open end of the bag so as to form flaps, said flaps beingloaded with such weight that when the bag is placed bottom down theflaps will fall out to the sides and thereby provide free and easyadmission to the interior of the bag.

The loading of the side-wa l flaps is preferably effected by means ofweighty strips provided at the free ends of the flaps.

When the package according to the invention consists only of the saidbag referred to in the following as the flap bag, the package is to beused in such cases where the surgical devices are sterilized in thehospitals. The said devices are placed separately or several together ina flap bag of suitable size and the bags are placed in a bowl or a trayand are sterilized by autoclaving. When the said device or devices is orare to be used one grasps the bottom of the flap bag, the bottom isturned downwards, and the flaps will fall out to the sides, whichprovides an easy and free admission to the contents of the bag. In thismanner a real unwrapping of the sterile device immediately prior to useis avoided, and the danger "ice of the device being made unsterile isreduced since it does not come into contact with the surrounding airbefore it is to be used, and not at all With the outer faces of the flapbag which might have become unsterile.

For storage of suture and ligature materials and other devices which areto be used only on one occasion and the final sterilization of which ismade on an industrial scale upon finished packages, the flap bag isaccording to the invention placed in a sealed outer bag of germ-tightmaterial having its bottom adjacent the extremity of the outer bagdestined to be opened. Thus, when the outer bag is opened by cutting ortearing, with the opening turned upwards, the bottom of the flap bagwill be apparent, and when grasping the bottom, pulling out the flap bagand turning the bag the flaps will automatically fall out to the sidesand the contents of the bag will become easily and freely accessible fordirect use. In this manner the contents of the flap bag will not comeinto contact with the outer faces of the flap bag having touched theedges of the outer bag, which edges might be unsterile, and it becomesunnecessary to carry out an additional tearing or cutting in order toget ac- CesS to the sterile surgical device in the inner bag, such ashas previously been the case.

In connection with surgical accessories having a considerable length itmay also be appropriate to make use of an outer germ-tight bag, whichmay then surround only the open end of the flap bag.

In the production of the flap bag it is appropriate to make use oftransparent foils of plastics which can be welded together by heating,e.g. by high-frequency welding. As examples of suitable plastics may bementioned ethylcellulose, cellulose acetate, cellulose propionate,cellulose acetate butyrate, polyamides, such as polyamino undecanoicacid, polyvinyl compounds, polyesters, polyethylene, polypropylene,polymonochlorotrifiuoroethylene and polytetrafluoroethylene. Use mayalso be made of laminates of two or more of the said plastics. Furtherpapers, such as parchment paper, are also applicable.

If the flap bag is used together with a sealed outer bag of germ-tightmaterial, the latter may also be produced from the same material as theflap bag. If the package according to the invention is used for sterilestorage of suture or ligature material requiring a conditioning duringthe storing period by the presence in the package of a water-containingmoistening agent being or the vapors of which being in contact with thesuture or ligature material, the sealed outer bag should be preparedfrom a material being impermeable or difiicultly permeable to the vaporsof the employed moistening agent. Suitable materials for the saidpurpose are foils produced from appropriate laminates of the abovementioned plastics or foils of nylon, polymonochlorotrifluoroethylene,polytetrafiuoroethylene or polyethylene glycolterephthalates. The sealedouter bag may also be produced from a laminated metallic foil, e.g.analuminum foil being coated at its inner face with a thin film ofpolyethylene or another plastic which may be welded by the action ofheat, and at its outer face with a thin layer of paper.

When selecting the material for the package according to the inventionregard should be taken not only to the manner in which sterilization hasbeen performed, but also to the purpose for which the package isintended. Some plastics, such as polyethylene, are not suitable when thesterilization takes place by autoclaving. When the package according inthe invention is used for sterile storage of suture and ligaturematerials in the presence of a water-containing moistening agent, it isof course necessary that the employed materials be unable to be affectedby the moistening agent and that the outer bag be impermeable thereto.The flap bag may be produced from a material being permeable to themoistening agent Q and its vapors, such as polyethylene, particularlywhen the moistening agent is placed in the space or interstice betweenthe flap bag and the sealed outer bag. This is, however, not absolutelyimperative since the vapors of the moistening agent can penetrate intothe flap bag through the slittered side-walls.

The invention is more fully explained in the following, reference beingmade to the drawing, on which FIG. 1 shows a flap bag according to theinvention of horizontal front view and containing a surgical device,

FIG. 2 shows a vertical cross section of the bag shown in FIG. 1 withthe flaps of the bag spread out to the sides,

FIG. 3 a front view of a suture material package according to theinvention,

FIG. 4 the same after the outer bag has been opened and the fiap bag hasbeen partially pulled out,

FIG. 5 the removed flap bag seen partially in section with the bottomdown, and the flaps spread out to the sides,

FIG. 6 a front view of another embodiment of a suture material packageaccording to the invention,

FIG. 7 the same after the outer bag has been opened and the flap bag hasbeen partially pulled out,

FIG. 8 the removed flap bag in perspective with the bottom down and theflaps spread out to the sides,

FIG. 9 a side-view of a package containing a catheter and FIG. 10 aside-view of another package also containing a catheter.

In FIGS. 1 and 2 1 designates a bag made from a foil of plastic, such aspolypropylene, by bending the foil for the formation of the bottom 2 ofthe bag and welding the side edges for the formation of the sealedside-walls 3 which extend only about one third of the length of the bag.How far in height the bag should be sealed in the sidewalls depends onthe surgical device to be contained in the bag.

The side-walls of the bag have at their free top ends thickenings forthe formation of strips 4 having such a a weight that the sidewalls-asshown in FIG. 2will spread out tothe sides in the form of flaps 5.

In the bag 1 is disposed a surgical device which in the shown embodimentconstitutes a blade 6 of a surgeons knife but which may be any otherdevice, the size of the bag and the length of the flaps 5 being adaptedto the size and form of the surgical device to be stored in the bag. Thebag may be provided with a weakened line 14 below the strips 4 and/ orwith a weakened line 15 above the sealed side-walls 3 in order tofacilitate the falling out of the flaps 5.

The bag shown in FIGS. 1 and 2 with the flaps 5 and the strips 4 is usedin the following manner:

The surgical device or devices to be sterilized is or are placed in thebag which is dimensioned to suit the size and form of the device inquestion, and the :bag is placed in a bowl, tray or other recipient andis autoclaved or sterilized in another manner. When the sterile deviceis to be employed, the bottom of the bag is grasped and the bag israised so as to make its bottom turn downwards. This causes the flaps 5to spread out to the sides so that the device in the bag will becomefreely and easily accessible.

It will be seen that at no time the sterile surgical device comes intocontact with the outer surfaces of the bag so that there is no danger ofthe device becoming unsterile even if the outer surfaces of the bag forsome reason or other have lost their sterility. Further it will be seenthat after the flaps 5 have spread out to the sides the sterile deviceis directly and easily accessible for the operator without having beenin the hands of any other person.

In FIGS. 3 to 5 '7 designates a suture'thread of silk, nylon or catgutcoiled up and kept together by means of a slip of paper 8 on whichinformation as to the type and length of the thread may be printed.Instead of the slip of paper 8 use may also be made of a wrapping or apacking of the thread in filtering paper or the like material. Thethread 7 is placed in a bag of similar construction as that of the bag 1in FIGS. 1 and 2, the bag being provided with a bottom 2,, side-walls 3which have been welded together and flaps 5. It differs from the bag inFIGS. 1 and 2 only in that the upper edges 9 of the sidewalls have beenbent and hold a piece of filtering paper 141 so that each of the edges 9and the pieces of filtering paper 10 form the strips of the bagcorresponding to the strips 4. In the pieces of filtering paper 10 awater-containing moistening agent is absorbed, such as ethanol, if thethread is produced from catgut. This is not necessary, when the threadis produced from silk or nylon and in such case the strips of the bagmay be formed in the same manner as in FIGS. 1 and 2.

The bag 1 is placed in a sealed outer bag formed from two aluminum foils11 provided at their inner surface with a layer of polyethylene orpolypropylene and at their outer surface with a layer of paper andunited with each other by weldings 12 along the edges. At the topportion at one side edge there is a notch 13 by means of which it iseasy to tear off the bottom of the outer bag when the package is to beopened.

In FIG. 4 such tearing off has been made and the bag 1 has been partlypulled out from the torn outer bag. When the bag thereafter iscompletely pulled out bottom down and is turned its flaps 5 will spreadout to the sides, such as shown in FIG. 5, and the suture material willbe easily and freely accessible without having been in contact with thetorn edges of the outer bag which will usually not be sterile at theoutsides.

In FIGS. 6 and 7 1 designates an inner bag made from a plastic foil suchas polypropylene, by bending the said foil for the formation of thebottom 2 of the bag. The side-walls of the bag are welded togethermerely at the bottom. Thereby long flaps S are formed. The latter haveat their top portion thickenings for the formation of strips 4 havingsuch weight that the, flaps 5 forming the sidewalls of the inner bagwill fall out to the sides when the bag is placed bottom down. Thestrips 4- may consist of the same material as the bag provided the saidmaterial is thicker, but they may also be made from narrow strips ofcardboard which have been glued to the flaps.

At the bottom of the inner bag there is provided a holding deviceconsisting in the shown embodiment of a vertical stiff strip 16,integral with a horizontal footing 17 which extends along the bottom 2of the bag 1 and is glued to the bottom 2. A suture thread 7 of silk,nylon or catgut is coiled up and placed in an envelope 18 being providedwith a pocket 19 wherein the strip 16 is pushed.

The inner bag 1 is placed in a sealed outer bag which is made from twoaluminum foils 11 provided at their inner surface with a layer ofpolyethylene or polypropylene and at their outer surface with a layer ofpaper and united with each other by weldings 12 along the edges. At thetop portion at one side edge there is a notch 13 by means of which it iseasy to open the outer bag.

In FIG. 7 such opening has been carried out and the bag 1 is partiallypulled out from the torn outer bag. When thereafter the bag 1 iscompletely pulled out bottom turned up and is turned 180, its flaps 5will because of the weight of the strips 4 fall out to the sides, suchas shown in FIG. 8.

Since the inner bag is pulled out from the outer bag bottom turned up,germs, if any, being present on the torn edges of the outer bag and onits outer sides will not be allowed to fall down into the inner bag andthereby give rise to a contamination of the contents of the inner bag.Further, the position of the surgical device in the inner bag will befixed since it is mounted on the holding device formed by the strip 16with the footing 17 at some distance from the bottom 2. Thus whengrasping the bottom of the inner bag 1 in order to pull it out from theouter bag, the surgeon will not accidentally grasp the envelope 18 andthereby impede removal of the inner bag.

As, moreover, the flaps are relatively long in that they extend down tothe bottom 2 of the bag 1, it'will be sufficient to provide for arelatively small weight of the strips 4, which reduces the weight of thepackage. If the flaps were shorter and in case the surgical device withbag that the side-walls of the bag swell in the position shown in FIG. 7one would even with a relatively considerable weight of the strips 4 runthe risk that the weight of the flaps be insufiicient to cause thelatter to fall out to the sides when the inner bag is pulled out fromthe outer bag and is placed bottom down.

The package shown in FIGS. 6 and 7 has a relatively small size and arelatively slight weight. In addition thereto a quick and easy removalof the surgical device and/or auxiliary being stored under sterileconditions is secured, which means that the risk of contaminating saiddevice or auxiliary during its removal is considerably reduced.

Though the package is illustrated in connection with a suture thread asthe surgical device and auxiliary, it may also be used in connectionwith other surgical devices and auxiliaries such as knives, haemostaticforcets and wound retractors. The holding device shown is to beconsidered as an illustrating embodiment, only. If desired, the packagemay be provided with several holding devices, in that each holdingdevice carries for instance a suture thread packed in an envelope, ifdesired.

In FIG. 9 a flap bag 20 provided with weighty strips 21 contains acatheter 22. The side-walls of the bag 20 are slitted up to the bottomof the bag and the catheter 22 is kept in place by means of two weldings23. The flap bag 20 is surrounded by an outer germ-tight bag 24consisting of a main portion 25 and a bottom portion 26, the latterbeing joined to the former at 27.

When the catheter in the package is to be used, the bottom portion 26 isremoved from tthe main portion 25 and the flap bag 20 is placed with thebottom down, which makes the catheter 22 accessible.

FIG. shows the same flap bag as in FIG. 9, but the outer germ-tight bagonly surrounds the lower part of the flap bag 20 to which the bag 28 isjoined at 29. When the outer bag 28 is released from the flap bag 20 andthe latter is placed with the bottom down, the catheter will beaccessible.

The principle of keeping the surgical device in place in the flap bag bymeans of the weldings 23 shown in FIGS. 9 and 10 may also be used inconnection with the flap bag shown in FIGS. 3 and 4, in which case thesidewalls of the flap bag are slitted up to the bottom of the bag, whichmakes it superfluous to seal the side-walls at their edges at the bottomof the bag.

The outer bag may also be produced from a plastic foil, e.g. nylon orpolyethylene which may be welded together by the action of heat.

The embodiment shown in FIGS. 3 to 8 may further be modified in that thesuture material is placed in a sealed bag containing a moistening agent,if desired, within the flap bag 1, but such modified embodiment is lessappropriate since it requires a special cutting or slitting in orderthat free admission to the suture material may be obtained.

In the foregoing sterilization by autoclaving is mentioned, but it isalso possible to use other sterilizing methods, such as drysterilization by ethylene oxide gas or sterilization by irradiation with8 or 'y rays.

We claim:

1. A package for sterile storage of suture and ligature material,haemostatic forcets, wound retractors, knives, catheters, and othersurgical devices which comprises an envelope for holding at least one ofsaid devices, said envelope having a closed bottom and sidewalls joinedwith one another a selected distance from the bottom of the envelope,said side walls being flexible and extending beyond the joined portionto form flaps, said flaps being loaded with such weight that when theenvelope is placed bottom down, said flaps fall out to the sides andthereby provide free and easy admission to the interior of the envelope.

2. A package according to claim 1, wherein said flaps are provided withweighty strips at their free ends.

3. A package according to claim 2, wherein said strips on the flaps ofthe envelope are formed by thickening of the flaps.

4. A package according to claim 1, in which holding means are providedat the bottom of the envelope for fixing the position of the surgicaldevice.

5. A package according to claim 4, in which the holding means comprisesa stiff projecting strip secured to the bottom of the envelope.

6. A package according to claim 5, in which said projecting strip isintegral with a footing, said footing extending along the bottom of theenvelope and secured thereto thereby securing said projecting strip tothe bottom of the envelope.

7. A package according to claim 5, in which said projecting strip isadapted to fit in a pocket in an additional envelope for the surgicaldevice.

8. A package for sterile storage of suture and ligature material,haemostatic forcets, wound retractors, knives, catheters and othersurgical devices in the presence of a water-containing moistening agenttherefor which comprises an envelope for holding at least one of saiddevices, said envelope having a closed bottom and sidewalls joined withone another a selected distance from the bottom of the envelope, saidside walls being flexible and extending beyond the joined portion toform flaps, said flaps being provided at their free ends with weightystrips of a porous material in which the moistening agent has beenabsorbed.

9. A package for sterile storage of suture and ligature material,haemostatic forcets, wound retractors, knives, catheters, and othersurgical devices which comprises an envelope containing at least one ofsaid devices, said envelope having a closed bottom and sidewalls joinedwith one another a selected distance from the bottom of the envelope,said side walls being flexible and extending beyond the joined portionto form flaps, said flaps being loaded with such weight that when theenvelope is placed bottom down, said flaps fall out to the sides andthereby provide free and easy admission to the interior of the envelope,and a germ-tight outer bag surrounding and sealing at least the top,open portion of said envelope.

10. A package for sterile storage of suture or ligature materialaccording to claim 9, in which said package contains a water-containingmoistening agent for said material.

11. A package for sterile storage of suture or ligature materialaccording to claim 9, in which holding means are provided at the bottomof the envelope for fixing the position of the surgical device.

12. A package for sterile storage of suture and ligature material,haemostatic forcets, wound retractors, knives, catheters, and othersurgical devices which comprises an envelope containing at least one ofsaid devices, said envelope having a closed bottom and sidewalls joinedwith one another a selected distance from the bottom of the envelope,said side walls being flexible and extending beyond the joined portionto form flaps, said flaps being loaded with such weight that when theenvelope is placed bottom down, said flaps fall out to the sides andthereby provide free and easy admission to the interior of the envelope,and a sealed outer bag of germ-tight material surrounding said envelope,the bottom of said envelope being adjacent the extremity destined to beopened of said outer bag.

13. A package for sterile storage of suture or ligature materialaccording to claim 9, in which the holding means comprises a stiffprojecting strip secured to the bottom of the envelope.

14. A package for sterile storage of suture or ligature materialaccording to claim 13, in which said projecting strip is integral with afooting, said footing extending along the bottom of the envelope andsecured thereto thereby securing said projecting strip to the bottom ofthe envelope.

15. A package for sterile storage of suture or ligature materialaccording to claim 13, in Which said projecting strip is adapted to fitin a pocket in an additional envelope for the surgical device.

8 References Cited by the Examiner UNITED STATES PATENTS 892,074 6/ 1908Obici. 1,240,880 9/1917 Rink 20616 1,962,900 6/ 1934 Hirsch.

FOREIGN PATENTS 314,166 6/1929 Great Britain.

10 LOUIS G. MANCENE, Primary Examiner.

THERON E. CONDON, Examiner.

J. M. CASKIE, Assistant Examiner.

1. A PACKAGE FOR STERILE STORAGE OF SUTURE AND LIGATURE MATERIAL,HAEMOSTATIC FORCEPS, WOUND RETRACTORS, KNIVES, CATHETERS, AND OTHERSURGICAL DEVICES WHICH COMPRISES AN ENVELOPE FOR HOLDING AT LEAST ONE OFSAID DEVICES, SAID ENVELOPE HAVING A CLOSED BOTTOM AND SIDEWALLS JOINEDWITH ONE ANOTHER A SELECTED DISTANCE FROM THE BOTTOM OF THE ENVELOPE,SAID SIDE WALLS BEING FLEXIBLE AND EXTENDING BEYOND THE JOINED PORTIONTO FORM FLAPS, SAID FLAPS BEING LOADED WITH SUCH WEIGHT THAT WHEN THEENVELOPE IS PLACED BOTTOM DOWN, SAID FLAPS FALL OUT TO THE SIDES ANDTHEREBY PROVIDE FREE AND EASY ADMISSION TO THE INTERIOR OF THE ENVELOPE.